Mylan Laboratories Limited - Unit 8 – FDA Warning Letter, Jun 5, 2019

The FDA inspected Mylan Laboratories Limited, Unit 8, in India from May 27 to June 5, 2019, identifying significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API). As a result, the firm's API are considered adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. The FDA deemed Mylan's initial response inadequate due to insufficient detail and evidence of corrective actions.

Key violations included the failure to establish adequate written procedures for raw material receipt, identification, testing, and handling, which led to nitrosamine impurities (NDMA and NDEA) in valsartan API, primarily from contaminated recovered solvents. The firm's investigations and testing for nitrosamines were found to be insufficient. Additionally, Mylan failed to adequately clean equipment and utensils, resulting in residual valsartan API contamination on non-dedicated equipment, indicating a risk of cross-contamination.

The FDA strongly recommended engaging a qualified CGMP consultant. Mylan is required to respond within 15 working days, detailing corrective actions and a prevention plan. Failure to rectify these deviations could lead to FDA withholding approval of new applications and refusing admission of Mylan's products into the United States, with potential implications for drug supply.